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Showing posts with the label PfizerInc

FDA advisors raise doubts about seasonal updates to Covid vaccines as with flu shots

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[ad_1] A person receives a COVID-19 vaccination dose, during a free distribution of COVID-19 rapid test kits for those who received vaccination shots or booster shots, at Union Station on January 7, 2022 in Los Angeles, California. Mario Tama | Getty Images The U.S. Food and Drug Administration 's independent panel of advisors raised doubts about the need to "periodically" update Covid vaccines, noting that it's unclear if the virus is seasonal like the flu. Advisors on Thursday unanimously voted that new jabs for the fall should be monovalent — meaning they are designed against one variant of Covid — and target one of the omicron XBB strains . Those are now the dominant variants nationwide.  But the original voting question included language about whether the panel recommends a "periodic update" to Covid shots.  Dr. Peter Marks, head of the FDA's vaccine division, asked the panel's chair to strike the wording from the question after severa

Providers struggle to get latest Covid shots into arms amid early supply issues

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[ad_1] New vaccine COMIRNATY® by Pfizer, available at CVS Pharmacy in Eagle Rock, California. Irfan Khan | Los Angeles Times | Getty Images It's déjà vu for some Americans looking for the latest Covid-19 vaccines. Certain people who were lucky enough to snag an appointment for the latest formulation are receiving cancellation notices or showing up to learn there isn't a dose available for them. Some are being told they need to pay more than $100 out of pocket because their insurance provider isn't covering the shots yet. The majority of CVS locations are able to honor scheduled appointments, but delivery delays to some stores are causing them to reschedule shots, a CVS spokesperson said in a statement. Most Walgreens stores have enough supply for existing appointments and more slots are being made available as the shots come in, a spokesperson said. Vaccine manufacturers Moderna and Pfizer said they have shipped millions of doses since the new versions were approve

Pfizer will have to pay rebates to Medicare for five drugs under Biden plan to lower Rx costs

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[ad_1] President Joe Biden delivers remarks about the Build Back Better legislation's new rules around prescription drug prices in the East Room of the White House on December 06, 2021 in Washington, DC. Chip Somodevilla | Getty Images Five of Pfizer's drugs will cost less for Medicare recipients starting next month as part of President Joe Biden's plan to lower prescription drug costs, the Department of Health and Human Services said Wednesday.  Pfizer's drugs are among the first set of 27 Part B prescription drugs that will be subject to Medicare inflation rebates starting April 1, according to the department. That requires Pfizer and other prescription drug companies to refund Medicare through rebates because the prices for those drugs rose faster than the rate of inflation.  Pfizer's drugs include the blood thinner Fragmin , which was approved by the Food and Drug Administration in 1994. It also includes Atgam , a medicine used to treat symptoms of Renal

Updated Covid vaccines need to target XBB omicron variants this fall, FDA staff says

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[ad_1] Syringe with Covid-19 vaccine against the XBB Variant. Fight against virus Covid-19 Coronavirus, Vaccination and immunization. Undefined Undefined | Istock | Getty Images U.S. Food and Drug Administration staff on Monday said updated Covid boosters should target XBB omicron subvariants for the upcoming fall and winter vaccination campaign.  The U.S. should use a monovalent vaccine targeting either XBB.1.5, XBB.1.16, or XBB.2.3, collectively the dominant strains nationwide, the staff said in a briefing document .  related investing news The FDA staff made the conclusion ahead of a meeting on Thursday, when a panel of external advisors to the agency will recommend a strain for new Covid shots to target later this year. There is no set date for when the vaccination campaign will begin. Vaccine manufacturers will be expected to update their shots once that strain is selected. Pfizer , Moderna and Novavax are already developing versions of their respective vaccines targeti

Weight loss drugs boost sales at retail pharmacies, but they may not help profits much

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[ad_1] A pharmacist displays boxes of Ozempic, a semaglutide injection drug used for treating type 2 diabetes made by Novo Nordisk, at Rock Canyon Pharmacy in Provo, Utah, U.S. March 29, 2023.  George Frey | Reuters Drugmakers aren't the only ones feeling the impact of the weight loss industry gold rush.  Retailers with pharmacy businesses, such as Walmart , Kroger and Rite Aid , said increased demand for prescription weight loss drugs helped boost sales for the second quarter.  But analysts note that those blockbuster treatments are minimally profitable for retail pharmacies – and may even come with margin headwinds. "More recently, you're starting to hear retailers talk about these drugs. But I wouldn't say they're necessarily beneficiaries of the increased popularity," Arun Sundaram, an analyst at CFRA Research, told CNBC. "They're really not making much of a profit on the drugs. So it's really just a traffic driver and not really a p

Pfizer RSV vaccine for infants has 'generally favorable' safety data, FDA staff say

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[ad_1] Blood sample for respiratory syncytial virus (RSV) test Jarun011 | Istock | Getty Images U.S. Food and Drug Administration staff on Tuesday said Pfizer's vaccine that protects infants from respiratory syncytial virus has "generally favorable" safety data. The FDA staff made the conclusion in briefing documents ahead of a meeting on Thursday when a panel of external advisors to the agency will discuss whether to recommend full approval of the RSV shot . The advisors will vote on whether Pfizer's late-stage clinical trial data on the vaccine supports its safety and efficacy. The FDA typically follows the advice of its advisory committees, but is not required to do so. The agency is slated to make a decision on whether to clear the shot in August before RSV season in the fall. If approved, Pfizer's jab would become the world's first vaccine that protects infants against RSV.  RSV usually causes mild, cold-like symptoms. But infants and older ad

New Covid boosters could reach Americans as soon as Thursday – here's what you need to know

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[ad_1] A nurse prepares doses of the Pfizer vaccine during a COVID-19 vaccination event at Josephine's Southern Cooking in Chatham, Illinois, Dec. 30, 2021. Brian Cassella | Tribune News Service | Getty Images A new round of Covid vaccines is finally here in the U.S. The Centers for Disease Control and Prevention cleared single-strain shots from Pfizer and Moderna for all Americans six months and up on Tuesday, following approvals from the Food and Drug Administration on Monday. Those mRNA vaccines are designed to target a relatively new omicron subvariant called XBB.1.5 .  The first doses of the new shots will be available at some pharmacies and other vaccine distribution locations within 48 hours of the CDC's recommendation, agency staff said Tuesday during a meeting of independent advisors to the CDC. That means jabs could reach Americans as soon as Thursday. Meanwhile, the FDA is still reviewing a third updated vaccine from Novavax for people ages 12 and up.  Th

Pfizer, GSK RSV shots for older adults may prevent thousands of hospitalizations, CDC analysis says

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[ad_1] Respiratory syncytial virus vial. Manjurul | Istock | Getty Images Vaccinating one million adults ages 65 and above with a single RSV shot from Pfizer or GSK may prevent thousands of hospitalizations over two seasons of the virus, according to a Centers for Disease Control and Prevention analysis .  A CDC medical officer presented the analysis, conducted by researchers at the University of Michigan, at an advisory committee meeting on Wednesday. The committee recommended that adults ages 60 and older may receive one dose of Pfizer's or GSK's respiratory syncytial virus shot after consulting their doctor.  The analysis found that vaccinating one million adults 65 and older with a single dose of Pfizer's shot may prevent 2,500 hospitalizations and 25,000 outpatient visits over two seasons of the virus. RSV season typically lasts from October to March in the Northern Hemisphere.   The analysis also found that vaccinating one million adults in the same age gr

Pfizer RSV vaccine for older adults should be monitored for nervous system condition Guillain-Barre, scientists say

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[ad_1] A health worker prepares a flu vaccine shot before administering it to a local resident in Los Angeles, the United States, on Dec. 17, 2022. Xinhua News Agency | Getty Images People who receive Pfizer 's RSV vaccine for older adults should be monitored for Guillain-Barre syndrome, after two people developed the nervous system disorder after they received the shot, scientists said in clinical trial results published in the New England Journal of Medicine. The scientists concluded the vaccine was effective in preventing lower respiratory tract illness in adults ages 60 and older without any evident safety concerns. But they flagged the Guillain-Barre cases as a potential cause for concern moving forward. "If RSVpreF vaccine is approved and recommended, these adverse events warrant close monitoring in future studies and with real-world data and postmarketing surveillance," the scientists wrote. The study, which published Wednesday, was supported by Pfizer. Guill

Pfizer says no major tornado damage to drug manufacturing areas of North Carolina facility

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[ad_1] In this aerial image, damage is seen to a Pfizer pharmaceutical factory after a tornado hit the facility two days earlier, on July 21, 2023 in Rocky Mount, North Carolina. Sean Rayford | Getty Images Pfize r on Friday said there does not appear to be major damage to the drug manufacturing areas of its plant in Rocky Mount, North Carolina , after a tornado hit the facility two days earlier.  The plant supplies nearly 8% of all sterile injectable medicines used in U.S. hospitals, including anesthesia, analgesia, therapeutics, anti-infectives and neuromuscular blockers. Pfizer added that the facility manufactures about 25% of the company's sterile injectables.  related investing news An initial assessment found that the tornado primarily damaged a warehouse facility, which stored raw materials, packaging supplies and finished medicines waiting to receive quality assurance, according to Pfizer.  The drugmaker did not say whether it expected that damage to lead to new drug

Pfizer Group B strep vaccine for infants returns encouraging mid-stage trial results

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[ad_1] Streptococcus agalactiae bacteria, responsible for vaginal and urinary tract infections and newborn infections including meningitis and septicemia. Optical microscopy view. Cavallini James | BSIP | Universal Images Group | Getty Images Pfizer on Wednesday said its experimental vaccine targeting the potentially deadly bacterial disease Group B Streptococcus returned strong mid-stage clinical trial results , a promising step as the drug inches toward potential approval. Pfizer is among several drugmakers racing to develop the world's first shot targeting Group B strep disease, which is linked to nearly 150,000 infant deaths worldwide each year, especially in lower-income countries. The Food and Drug Administration in September granted breakthrough therapy designation to Pfizer's vaccine, which is intended to expedite the development and review of the shot.  Pfizer's single-dose shot generated antibodies that may provide infants with meaningful protection aga

EU expands Wegovy, Ozempic probe over suicide risks to include other weight loss, diabetes drugs

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[ad_1] In this photo illustration, boxes of the diabetes drug Ozempic rest on a pharmacy counter in Los Angeles, April 17, 2023. Mario Tama | Getty Images The European Union's drug regulator on Tuesday said it has broadened an investigation into the risk of suicidal thoughts and self-injury among patients taking Novo Nordisk 's Ozempic, Wegovy and Saxenda drugs to include other weight loss and diabetes medications.  The European Medicines Agency didn't specify which additional drugs are now included in the investigation. But it could potentially include Eli Lilly 's diabetes drug Mounjaro, which is approved in the EU . Other companies such as Pfizer and Amgen are developing similar products.  The EMA said it is now evaluating about 150 reports of possible cases of self-injury and suicidal thoughts in patients taking weight loss and diabetes drugs. It's still unclear if the medicines caused the events or whether they are linked to patients' underlying